BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5548132 · Received April 5, 2016

    Report

    Report Number
    3002807576-2016-00013
    Event Type
    Malfunction
    Date Received
    April 5, 2016
    Date of Event
    March 16, 2016
    Report Date
    April 5, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT WAS SCHEDULED TO HAVE AN MRI SCAN FOR HIS KNEE WHICH WAS UNRELATED TO THE DEEP BRAIN STIMULATOR (DBS). DURING IMPEDANCE TESTING PRIOR TO THE SCAN IT WAS NOTED THAT ELECTRODE 11 HAD OUT OF RANGE IMPEDANCE READINGS; THE MRI WAS NOT PERFORMED DUE TO THIS ISSUE. ALL OTHER ELECTRODES WERE WITHIN NORMAL RANGE. IMPEDANCE READINGS WERE: C<(>&<)>11 ¿ 11653 OHMS, 8<(>&<)>11 ¿ 13856 OHMS, 9<(>&<)>11 ¿ 15047 OHMS AND 10<(>&<)>11 ¿ 12435 OHMS. THE PATIENT HAD RECENT FALLS, ONE OF WHICH HE HAD HIT HIS HEAD NEAR THE RIGHT BRAIN LEAD AND ANOTHER FALL WHERE HE HIT THE INS. THE DBS WAS STILL FUNCTIONING NORMALLY AND HE HADN¿T EXPERIENCED ANY CHANGE IN SYMPTOMS AS A RESULT OF HIS RECENT FALLS. ELECTRODE 11 WAS NOT CURRENTLY PROGRAMMED SO THE PATIENT¿S MANAGING NEUROLOGIST CHOSE NOT TO DO ANY FURTHER TROUBLESHOOTING. NO ACTIONS/INTERVENTIONS WERE TAKEN AND THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. THE ELECTRODE WITH HIGH IMPEDANCES WAS NOT BEING USED; HOWEVER, THE COMPROMISE TO THE SYSTEM RESULTED IN HIM NOT BEING ELIGIBLE FOR AN MRI. NO SURGICAL INTERVENTION WAS PLANNED OR PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203292 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR